Be fully responsible for maintenance and repair of process equipment at Gracell Biotech Co., Ltd. (Suzhou Buildings 8 and 12, and the Shanghai Xinsi PD laboratory); primary base in Suzhou.
Respond promptly to maintenance and repair requests covering isolators, bioreactors, incubators, sterilizers/autoclaves, biological safety cabinets, as well as QC and PD equipment.
Assist in establishing and optimizing the equipment lifecycle management system; strictly implement and record activities according to relevant SOPs.
Be responsible for procurement and inventory management of GMP spare parts for process equipment.
Execute annual, semi-annual, quarterly, and monthly maintenance for production, QC, warehouse, and PD equipment.
Participate in user requirements development and design qualification; support equipment acceptance, commissioning, qualification, and validation.
Participate in quality activities such as...
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